Our area of Expertise


Compilation of dossier as per latest country specific guidelines

  • Dossier compilation as per :
    • - Common Technical Dossier (CTD) Guidelines.
    - Asean Common Technical Dossier (ACTD)
       Guidelines.
    - Country specific.

  • Drug master file (DMF) compilation for
        open and closed parts.

  • Drafts data for
    • - BMR, MFR
    - Process Validation,
    - Stability Study reports,
    - Dissolution profile,
    - Certificate of analysis and related reports

  • Reports on
    • - Bioavailability / Bioequivalance Studies,
    - Clinical Trials studies
    - Justification for fixed dose combination
    - Prepare Periodic Safety Update report PSUR).
    - Preclinical studies like Toxicity, subacute,
      acute; Carcinogenicity, Teratology &
      Reproduction toxicity

  • Prepare Summary of product (SPC),
      Pack Insert, Product rationale.

  • Expert Reports
    • - Quality,
    - Pre-clinical,
    - Clinical

  • Overviews (Module 2)
    • - Clinical
    - Non-Clinical

  • Nonclinical Study Reports (Module 4)

  • Clinical Study Reports (Module 5)

  • Ready dossiers available in ACTD, CTD, Asian, African, CIS, Central America, South America, North America.

  • Dossier conversion from one country to another)

  • Registration Assistance

  • Technology Transfer Dossiers Disposable
         Surgical Items


    • Technology Transfer
    We with help of our team of Development department we under take projects of development of various pharmaceutical products. We help in

    • Evaluation of your development needs
    • Identifying API sources
    • Analytical method development, formulation development, product / technology know-how
    • Manufacturing of Pivotal scale-up & registration batches, stability studies, dossier compilation for regulatory submission and commercial production
    Technology Transfer & Manufacturing
    We also help in transferring technology from your lab / facility to ours, Perform method transfer / validation, execute scale-up and exhibit batches, stability studies, dossier compilation and commercialize the product in various other countries.

    Our Speciality
    • Technology of
    • Metered Dose Inhaler (MDI)
    • Dry Powerdered Inhaler (DPI)

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      + 91 22 - 25691939 / 25612751
      enquiry@labeladossier.com